The investigators hypothesis is that local activation of the endogenous Lp-PLA2 plays an integral role in early atherosclerosis, and contributes to the mechanism of coronary endothelial dysfunction and to the structural and mechanical properties that characterize plaque vulnerability. Thus, our study will characterize prospectively the correlation between the functional and structural vascular wall properties, and the activity of the Lp-PLA2 pathway.

Following recruitment of the total study population and 6-months therapy with the Lp-PLA2 inhibitor, we will evaluate whether: 1. Plaque lipid content correlates with Lp-PLA2 levels and endothelial function 2. Lp-PLA2 inhibition reduced coronary plaque lipid content

Estimated Enrollment:

80

Study Start Date:

January 2010

Estimated Study Completion Date:

May 2015

Estimated Primary Completion Date:

May 2015 (Final data collection date for primary outcome measure)

Intervention Details:

Device: LipiScan/LipiScan IVUS

Evaluation of the coronary artery using near infrared spectroscopy using either a LipiScan catheter or a LipiScan/IVUS catheter following a clinically indicated coronary angiogram and endothelial function testing with a positive diagnosis of endothelial dysfunction. The procedure is repeated following 6 months of Lp-PLA2 inhibition.

Detailed Description:

The present study will be a substudy of our National Institute of Health (NIH) funded and Institutional Review Board (IRB) approved (08-008161) protocol "Lp-PLA2 and Coronary Atherosclerosis in Humans" and (10-000044) "Lp-PLA2 and Coronary Atherosclerosis in Humans AIM III" in which the investigators are examining the impact of long-term inhibition of Lp-PLA2, with a specific novel inhibitor, on LpPLA2 activity and improvement in coronary endothelial function.

The substudy will allow the investigators to also examine the additional endpoint of lipid core content of atherosclerotic plaques and hence plaque vulnerability. Plaque lipid composition will be measured using the LipiScan or LipiScan IVUS catheter (InfraReDx NIRS(Near Infrared Spectroscopy) System with or without IVUS (Intra Vascular Ultrasound) capability) at baseline and again at 6 month following Lp-PLA2 inhibition.

The study will provide insight into the role of the endogenous Lp-PLA2 in early coronary atherosclerosis, a potential therapeutic target for early coronary atherosclerosis in humans.

myocardial infarction or angioplasty within 6 months prior to entry into the study

use of investigational agents within 1 month of entry into the study

patients who require treatment with positive inotropic agents other than digoxin during the study

patients with cerebrovascular accident within 6 months prior to entry the study

significant endocrine, hepatic or renal, disorders, local or systemic infectious disease within 4 weeks prior to entry into study

pregnancy or lactation

mental instability

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01581632